CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 43 enrolled
Drug / intervention
Wilatedrug
Likely dose
Wilate 500 IU or 1000 IU per vial (intravenous injection); dose not fully specified in available textAI-extracted
Key inclusion· 4
  • ✓Age ≥6 years at screening
  • ✓VWD type 1 (VWF:RCo <30 IU/dL), 2A, 2B, 2M, or 3 requiring substitution therapy
  • ✓Currently on on-demand VWF-containing product treatment with ≥1 and average ≥2 documented spontaneous bleeding episodes per month in last 6 months, with at least 2 requiring VWF-containing product treatment
  • ✓Available reliable records of bleeding episode type, frequency, and treatment for ≥6 months of prior on-demand treatment
Key exclusion· 12
  • ✕No reliable records available to evaluate bleeding episodes over ≥6 months of prior on-demand treatment
  • ✕History or current suspicion of VWF or FVIII inhibitors
  • ✕Thromboembolic event within 1 year before enrollment
  • ✕Severe liver disease (ALAT/ASAT >5× upper limit of normal) or kidney disease (creatinine >120 µmol/L)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04052698
NCT04052698Phase 3Completed
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Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With Von Willebrand Disease (VWD)

Octapharma·interventional·Posted Aug 12, 2019·Updated Oct 25, 2023

In Brief

A Phase 3 clinical trial evaluating Wilate for Von Willebrand Diseases. Completed, enrolled 43 participants across 14 sites in 8 countries.

Detailed Summary

This is a prospective, non-controlled, international, multi-center phase 3 study investigating the efficacy and safety of Wilate in previously treated adult patients with VWD, to obtain additional data on the safety and efficacy of Wilate in previously treated patients with VWD undergoing regular prophylaxis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVon Willebrand Diseases
CountriesBelarus, Bulgaria, Croatia, Hungary, Lebanon, Russia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedAug 12, 2019
Enrollment StartJun 18, 2020
Primary CompletionApr 23, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.9 years ago

Interventions

Wilatedrug

Produced from the plasma of human donors, Wilate is presented as a powder or solvent for intravenous injection containing normally 500 IU or 1000 IU human VWF and human FVIII per vial. The ratio between VWF ristocetin co-factor activity (VWF:RCo) and FVIII:C is 1:1. The product contains approximately 100 IU/ml human VWF when reconstituted with 5ml/10mL water for injection with 0.1% polysorbate 80. The specific activity of Wilate is ≥67 IU VWF:RCo/mg protein. The injection or infusion rate should not exceed 2-3mL per minute.